JPRN-jRCT2080223833UnknownPhase 2
A Randomized, Double-blind, Double-dummy, Multicenter, Adaptive Design, Dose Escalation (Part 1) and Dose-Response (Part 2) Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery
Conditions
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Janssen Pharmaceutical K.K.
- Enrollment
- 150
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 50age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •Weight greater than or equal to (>=) 40 kg to less than or equal to (<=) 150 kilogram (kg)
- •- Medically appropriate for postoperative anticoagulant prophylaxis as determined by the investigator
- •- Has undergone an elective primary unilateral total knee replacement (TKR)
- •- Before randomization, a woman must not be of childbearing potential defined as postmenopausal (defined as no menses for 12 months without an alternative medical cause) and/ or permanently sterile (include
- •hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy)
- •- Contraceptive use by men should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
Exclusion Criteria
- •- Any condition for which the use of apixaban is not recommended in the opinion of the investigator
- •- Bilateral, revision or unicompartmental procedure
- •- Known or suspected hypersensitivity or intolerance to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies or antibody fragments, or any of the excipients of JNJ-64179375
- •- Unable to undergo venography
- •- Known previous deep vein thrombosis (DVT) in either lower extremity
Investigators
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